Abstract

OVERVIEW OF REGULATIONS ON GMP COMPUTERIZED SYSTEMS

D. Chandra Sai*

Abstract

During the manufacturing and testing of the pharmaceutical products firms uses different automated solutions at various manufacturing steps. In recent times automation and digitalization playing a big role in the industry from development to distribution of product to patient. Computer or related systems and electronic records vastly involve in the pharmaceutical manufacturing process. There are certain guidelines established from different global regulatory bodies to ensure the manufacturing and testing of drug products using computerized process is appropriate and equal to controlled manual process. Complying with these guidelines or requirements is more crucial for each pharmaceutical firm to get approval to market the drug products to respective regions.

Keywords: Predicate rules, 21 CFR Part 211, 21 CFR Part11, EU Annex 11, computerized system, Electronic records.